JP2024503093A - Contoured bone plate with locking screws for bone compression specifically over the tarsometatarsal joint - Google Patents

Abstract

A method of applying a bone plate across two different portions of a tarsometatarsal joint or metatarsal may include placing the bone plate across the separation between the two bone portions. The bone plate can have at least two fixation holes and a bend between the holes. A locking screw can be inserted through one or both holes having head threads and shaft threads, the shaft threads having a pitch greater than the pitch of the head threads. The locking screw can be screwed into the underlying bone portion until the bend of the bone plate is deformed.

Description

Related Matter This application claims the benefit of U.S. Provisional Patent Application No. 63/138,726, filed January 18, 2021, the entire contents of which are incorporated herein by reference.

TECHNICAL FIELD This disclosure relates to bone plates and methods for fixating bones using bone plates, including compressing opposing bone ends together using the bone plate.

Background Bones, such as those in the foot, may be anatomically misaligned. In certain situations, surgical intervention is required to accurately align the bones to reduce patient discomfort and improve the patient's quality of life. Surgical intervention may involve cutting one or more of the misaligned bones and then physically realigning the bones to an anatomically corrected position. A bone plate or plates may be used to hold the bone in an anatomically corrected position and may help prevent the bone from returning to a displaced position.

SUMMARY Generally, the present disclosure is directed to bone plates and screws, systems incorporating bone plates and screws, and methods of using bone plates. In some instances, facilitates compression (e.g., angular compression) between opposing ends of two bone parts to which the bone plate is attached, which may be different parts of the same bone or two different bones separated by a joint. Bone plate systems and techniques are described. The forces generated by the plate fixation system are such that, for example, the epiphyses are pressed together such that there is a greater force on the side of the epiphysis opposite the plate than on the side of the epiphysis that is closer to the plate. may be asymmetrically distributed over the plane of the This may help facilitate angular correction of the bone portions relative to each other and/or promote healing (eg, fusion) between the bone portions in the corrected orientation.

In some implementations, the bone plate includes an elongate body having a length that is greater than the maximum width and thickness. For example, the bone plate may have a length sized to span the tarsometatarsal joint separating the metatarsals from the opposing cuneiforms. The bone plate may include a bend that displaces a portion of the bone plate positionable over the joint between two bone portions away from the joint. As a result, the bone plate can include a first end contacting one bone portion and a second end contacting a second bone portion, the intermediate portion between the two ends being , displaced from one or both bone parts and/or a joint between two bone parts.

In order to secure the bone plate to the bone part, the bone plate has at least one fixation hole positionable on the first bone part and at least one additional fixation hole positionable on the second bone part. A plurality of fixation holes extending through the bone plate can be included, including a plurality of fixation holes extending through the bone plate. One or more of these fixation holes may include a threading that partially or completely surrounds the fixation hole and engages a threading on the head of a locking screw that is insertable through the fixation hole into the underlying bone. It may also be possible to facilitate the

at least one for both securing the locking plate to the underlying bone portion and achieving compression between the ends of two bone portions that are secured together with the bone plate according to some examples. Two locking screws may be used, the locking screw both engaging the bone plate and deforming the bone plate when driven beyond its initial engagement position within the bone plate. It is configured as follows. For example, when an arch within a bone plate is physically deformed toward a flat or unflexed profile (e.g., resulting in a residual arch with a lower height after deformation), the underside of the plate is placed under tension. The upper side of the plate may then be placed under compression. As a result, a moment force can be applied that has an asymmetrically distributed magnitude across the end surface of the bone being compressed. When used, the locking screw may be configured to engage the bone plate and deform the bone plate by controlling the compression ratio of the locking screw. The compression ratio of the bone screw is controlled by adjusting the pitch of the threads on the head of the screw relative to the pitch of the threads on the shaft of the screw, and/or by controlling the lead of the head relative to the lead of the shaft. obtain.

Conventional bone plate systems utilize one of two different types of screws: compression screws or locking screws. A compression screw is a screw that has a threaded shaft but no threaded head. In use, the compression screw can be driven until the head of the screw contacts the bone plate and then driven further into the bone to compress the bone plate. In contrast, a locking screw has both a threaded head and a threaded shaft. However, locking screws are generally designed to be screwed onto the bone plate without causing any compression until the threaded head engages with a mating threading on the bone plate.

According to some examples of the present disclosure, the bone plate includes both an engagement between the head of the screw and a mating threading around a fixation hole on the bone plate, and compression of the bone plate during rotation. One or more locking screws are provided to achieve this. The pitch of the threads on the shaft of the screw may be sufficiently greater than the pitch of the threads on the head of the screw to achieve both engagement and compression. Additionally or alternatively, the threaded lead on the shaft is larger than the threaded lead on the head to generate a compressive force when the locking screw is inserted into the underlying bone. Good too. In either case, the threading on the screw head rotates into engagement with the mating threading around the fixation hole, so that the threading on the shaft causes the bone plate engaged with the threading on the head to move downwardly toward the bone. You can continue to pull. As a result, the bend of the bone plate may deform (e.g., elastically and/or plastically) toward the bone portion being fixed.

In some examples, the bone plate is provided with one or more locking screws configured for both engagement and compression with the bone plate. The bone plate has a bent portion. The bending portion may be a region of the bone plate between one or both ends and opposing ends of the bone plate that are non-planar (eg, prior to deformation and/or installation). The bend portion may be offset from the end in one or more planes. For example, when one end of the bone plate is placed in contact with one bone portion and the second end of the bone plate is placed in contact with the other bone portion, the bending portion of the bone plate at the bending portion is A gap may be defined between the bone-facing surface and the surface of the underlying bone(s). This gap may be reduced or eliminated through flattening of the bend upon installation of one or more locking screws that are also configured to achieve compression.

With the bending portion of the bone plate positioned over the joint between two bone portions to be secured together, one or more locking screws configured for compression are attached to corresponding portions within the bone plate. It may be placed into the underlying bone through the fixation hole. Once the one or more locking screws are installed, the bending portion within the bone plate may deform toward the articulation between the two bone portions. When a bone plate is deformed from an initial flexure to a reduced flexion profile, the bone plate experiences forces on the cortex of the bone opposite the plate that are greater than forces on the cortex of the bone closest to the plate, for example. may be used to function as a spring, providing a distributed load across the end surfaces of the bones that are pressed together. As a result, the force provided by the tensioned bone plate can be angular and serve, for example, to enhance bone repositioning performed prior to fixation using the bone plate.

In some examples, a bone plate having a bending portion may be placed over the joint between two adjacent bone portions to be fixed, and one or more locking screws configured for compression. may be placed into the underlying bone portion through fixation holes in the bone plate. One or more additional screws (e.g., compression screws, locking screws not configured for compression) may also be inserted into the one or more underlying bone portions through the one or more fixation holes in the bone plate. may be installed.

Additionally or alternatively, one or more drive pins may be used to assist in placement and pre-compression of the bone plate prior to screw placement. In use, the drive pin may include a threaded head, a shaft, and an enlarged region having a cross-sectional area greater than the cross-sectional area of the fixation hole into which the drive pin head is inserted. The one or more drive pins can be installed into the underlying bone portion through fixation holes in the bone plate, for example, by screwing the distal head of the one or more drive pins into the underlying bone portion. As the drive pin is driven deeper into the underlying bone portion, the enlarged region of the drive pin can be pressed against the upper surface of the bone plate adjacent the corresponding fixation hole. This can cause the bone plate to be compressed towards the bone portion that is being fixed. One or more individual drive pins can then be removed and corresponding screws installed to complete the installation process.

In still further examples, the bone plate having the bending portion is mounted (and any screws or optionally driven It may be pre-deformed (e.g. pre-compacted) (prior to installation of the pin). For example, using manual manipulation and/or a bending instrument, the bending portion of the plate may be compressed toward a more planar shape and held in compression while being placed across the joint between the bony portions being fixed. You can. The bone screw and/or drive pin may then be installed through the fixation hole in the bone plate while being held in compression. One exemplary bending device that may be used is a pair of plate bending arms that are inserted through a fixation hole (e.g., into a drill guide placed within the fixation hole) on either side of the apex of the bend portion, which It is then used to manipulate the bone plate.

In one example, a method of applying a bone plate across the tarsometatarsal joint is described. The method includes placing a bone plate over the tarsometatarsal joint separating the metatarsal from the cuneiform. The bone plate has a first fixation hole, a second fixation hole, and a bend between the first fixation hole and the second fixation hole. Positioning the bone plate over the tarsometatarsal joint includes positioning the flexure over the tarsometatarsal joint using a gap between the bony facing surface of the bone plate and the tarsometatarsal joint. . The method also involves inserting a locking screw through the first fixation hole. The locking screw has a head with a head thread and a shaft with a shaft thread. The shaft thread has a pitch greater than the pitch of the head thread, and the first fixation hole includes a thread for engaging the head thread. The method includes: threading the locking screw into the metatarsal or cuneiform bone below the first fixation hole until the head threads of the locking screw engage the threads defined by the first fixation hole; It further includes screwing a locking screw into the metatarsal or cuneiform bone, thereby deforming the bend of the bone plate toward the tarsometatarsal joint.

In another example, an orthopedic fixation system is described. The system includes a bone plate having a length defining a longitudinal axis extending from a proximal end of the body to a distal end of the body. The bone plate has a top surface, a bone-facing surface opposite the top surface, and includes a first fixation hole extending through the body and a second fixation hole extending through the body. The length of the bone plate is such that one of the first fixation hole and the second fixation hole is placed on the metatarsal bone, and the other of the first fixation hole and the second fixation hole is placed on the cuneiform bone. It is sized so that it crosses the tarsometatarsal joint when placed in the position. At least the first fixation hole includes a thread, and the bone plate has a first fixation hole and a second fixation hole. including a bend that offsets the portion of the bone plate between. The system also includes a locking screw having a head with a head thread and a shaft with a shaft thread, the shaft thread having a pitch greater than the pitch of the head thread. The locking screw exhibits a compression ratio defined by the pitch of the shaft threads divided by the pitch of the head threads. The locking screw is configured to be inserted through the first fixation hole into at least one of the metatarsals and the cuneiform, and the head screw has a threading defined by the first fixation hole. engaged. The compression ratio is effective to deform the bone plate when the head screw thread is fully engaged with the threading defined by the first fixation hole and the screw is further rotated.

In another example, a bone plate having a first fixation hole, a second fixation hole, and a bend between the first fixation hole and the second fixation hole is provided such that the bone plate is flat with respect to the bend. A method is described that includes tensioning the bone plate by bending it toward a profile that is tensioned, thereby providing a tensioned bone plate. The method includes placing a tensioned bone plate across the tarsometatarsal joint separating the metatarsal from the cuneiform and inserting a locking screw through the first fixation hole. The locking screw has a head with a head thread and a shaft with a shaft thread. The shaft thread has a pitch greater than the pitch of the head thread, and the first fixation hole includes a thread for engaging the head thread. The method also includes screwing the locking screw into the metatarsal or cuneiform bone below the first fixation hole until the head threads of the locking screw engage the threads defined by the first fixation hole. and, including.

The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.

FIG. 3 is a side view of an exemplary bone plate that may be used to achieve both fixation and compression across two bone segments. FIG. 3 is a top view of an exemplary bone plate that may be used to achieve both fixation and compression across two bone segments.

3 is a side view of an exemplary locking screw that may be used with the bone plate of FIGS. 1 and 2; FIG.

3 is an illustration of the exemplary bone plate of FIGS. 1 and 2 secured to a first bone portion and a second bone portion across a joint between the two bone portions; FIG.

3 illustrates an exemplary application of the bone plate of FIGS. 1 and 2 using first and second locking screws; FIG. 3 illustrates an exemplary application of the bone plate of FIGS. 1 and 2 using first and second locking screws; FIG. 3 illustrates an exemplary application of the bone plate of FIGS. 1 and 2 using first and second locking screws; FIG.

FIG. 2 is a flow diagram illustrating an example technique for installing a bone plate system according to the present disclosure.

FIG. 3 is a side view of an exemplary drive pin that may be used to assist in attaching a bone plate to bone.

9 is a side view of the example bone plate showing the example drive pin of FIG. 8 inserted through the fixation hole of the bone plate. FIG.

FIG. 6 illustrates exemplary procedural steps for attaching a bone plate to the medial cuneiform and the first metatarsal separated by the tarsometatarsal joint. FIG. 6 illustrates exemplary procedural steps for attaching a bone plate to the medial cuneiform and the first metatarsal separated by the tarsometatarsal joint. FIG. 6 illustrates exemplary procedural steps for attaching a bone plate to the medial cuneiform and the first metatarsal separated by the tarsometatarsal joint. FIG. 6 illustrates exemplary procedural steps for attaching a bone plate to the medial cuneiform and the first metatarsal separated by the tarsometatarsal joint. FIG. 6 illustrates exemplary procedural steps for attaching a bone plate to the medial cuneiform and the first metatarsal separated by the tarsometatarsal joint. FIG. 6 illustrates exemplary procedural steps for attaching a bone plate to the medial cuneiform and the first metatarsal separated by the tarsometatarsal joint.

10-15 illustrates example procedural steps that may be performed after the procedural steps described with respect to FIGS. 10-15. 10-15 depicts example procedural steps that may be performed after the procedural steps described with respect to FIGS. 10-15. 10-15 depicts example procedural steps that may be performed after the procedural steps described with respect to FIGS. 10-15. 10-15 depicts example procedural steps that may be performed after the procedural steps described with respect to FIGS. 10-15. 10-15 illustrates example procedural steps that may be performed after the procedural steps described with respect to FIGS. 10-15. 10-15 illustrates example procedural steps that may be performed after the procedural steps described with respect to FIGS. 10-15. 10-15 depicts example procedural steps that may be performed after the procedural steps described with respect to FIGS. 10-15.

FIG. 7 illustrates exemplary procedural steps for pre-tensioning a bone plate prior to installation. FIG. 7 illustrates exemplary procedural steps for pre-tensioning a bone plate prior to installation.

DETAILED DESCRIPTION The present disclosure generally relates to bone plates, systems, and kits that include one or more bone plates and screws, and methods of using one or more bone plates and corresponding screws. In exemplary applications, bone plate and screw systems according to the present disclosure may be used in bone alignment, osteotomies, fixation procedures, fracture repair, and/or other procedures in which one or more bones are set in a desired position, etc. may be useful for internal fixation of one or more bones during surgical procedures. Such procedures are performed when bones are relatively small compared to bones in other parts of the human anatomy, such as bones of the foot or hand (e.g. separated by joints or different parts of a single bone). can be performed on adjacent bones). In one example, one implementation of a bone plate and screw system to correct the alignment between a metatarsal (e.g., first metatarsal) and cuneiform (e.g., medial cuneiform), such as in a bunion correction. Treatments that utilize morphology can be performed. An example of such a procedure is the Lapidus method. In another example, the treatment can be performed by correcting the alignment of the metatarsals (eg, the first metatarsal). An example of such a procedure is a basal metatarsal osteotomy procedure.

Exemplary screw configurations and methods of installing bone plate and screw systems according to the present disclosure are described in more detail with respect to FIGS. 3-24. However, an exemplary bone plate that may be used in accordance with the present disclosure will first be described with respect to FIGS. 1 and 2.

1 and 2 are side and top views, respectively, of an exemplary bone plate 10 that may be used to achieve both fixation and compression across two bone segments. Bone plate 10 defines a body 12 having a central longitudinal axis 14 . The body of bone plate 10 has a top surface 16 and a bone-facing surface 18 , with bone-facing surface 18 being opposite top surface 16 of body 12 . In some implementations, bone plate 10 is positioned such that bone-facing surface 18 joins and/or contacts one or both bone portions along at least a portion of the length of longitudinal axis 14. For convenience, a "bone-facing surface" refers to when the plate is placed over one or more bones, regardless of whether there is more than one surface that contacts the bone when the bone plate 10 is applied. refers to the side of the bone plate that generally faces the bone.

The body 12 of the bone plate 10 defines a distal region 20 at or near a first end 22 and a proximal region 20 at or near a second end 26 opposite the first end of the body. A region 24 may be defined. Distal region 20 may be separated from proximal region 24 by intermediate region 28. For example, bone plate 10 can include one or more fixation holes extending through the thickness of body 12. In these examples, body 12 includes one or more fixation holes in distal region 20, one or more additional fixation holes in proximal region 24, and disposed between distal region 20 and proximal region 24. An intermediate region 28 without fixed fixation holes can be included.

In the example shown in FIGS. 1 and 2, the distal region 20 of the bone plate 10 has at least one fixation hole, shown as two fixation holes 30 and 32. Proximal region 24 also has at least one fixation hole, which is also illustrated as two fixation holes 34 and 36. The first fixation hole 30 extending through the body 12 in the distal region 20 is the fixation hole closest to the intermediate region 28 on the distal side of the bone plate, which, as described below, A bend may be included that offsets the intermediate region from a certain bone surface. The second fixation hole 34 extending through the body 12 in the proximal region 24 is the fixation hole closest to the intermediate region 28 on the proximal side of the bone plate. The third fixation hole 32 in the illustrated example is located between the first fixation hole 30 and the first end 22 of the bone plate. Fourth fixation hole 36 in this example is located between second fixation hole 34 and second end 26 of the bone plate.

Each feature described as a fixation hole may be an opening extending through the thickness of body 12 sized to receive a corresponding screw. Each fixation hole may typically have a circular cross-sectional shape, but may have other cross-sectional shapes without departing from the scope of this disclosure. The fixation holes may extend vertically through the thickness of the body 12 or may be tapered (e.g., such that the holes are larger adjacent the upper surface 16 than the adjacent bone-facing surface 18). ). In yet other examples, the fixation holes may extend at non-vertical angles through the thickness of the body 12 and/or may be configured for polyaxial screw alignment.

Although bone plate 10 is illustrated as configured with four fixation holes 30, 32, 34, and 36, the bone plate may include fewer or more fixation holes. For example, distal region 20 and proximal region 24 of bone plate 10 may each include fewer fixation holes (eg, one) and/or more fixation holes (eg, three, four). The dimensions (eg, length) of distal region 20 and proximal region 24 can be adjusted to accommodate the particular number of fixation holes included. Additionally, although the fixation holes on the bone plate 10 are illustrated as being coaxial with each other along the longitudinal axis 14 of the bone plate, the bone plate may have fixation holes that each extend away from the longitudinal axis. may include one or more branches that include. As a result, one or more fixation holes in these branch(s) may be non-collinear with the remaining coaxially arranged fixation holes. For example, in various examples, the bone plate 10 extends from the longitudinal axis 14 of the bone plate to define at least one of a Y-shape, an L-shape, a T-shape, a U-shape, and/or other shape profiles. It may include at least one outwardly extending branch.

Bone plate 10 may include a bend 40 . The bend 40 may be a portion of the bone plate 10 that is out of one or more planes in which the first fixation hole 30 and the second fixation hole 34 are located. In some examples, first end 22 and second end 26 of bone plate 10 are coplanar (e.g., such that the ends of the bone plate can be placed in the same plane). ). The bend 40 may offset at least a portion of the bone plate 10 from the plane in which the first end 22 and second end 26 are disposed.

As described, when a bone plate 10 including a bend 40 is placed across a joint between two bone portions, at least a portion of the distal region 20 (e.g., including the first end 22) , may contact one bone portion, and at least a portion of proximal region 24 (eg, including second end 26) may contact the other bone portion. The bend 40 may lift a portion of the bone plate 10 from the surface of one or both bone portions spanning the joint. As a result, a gap may exist between the bone-facing surface 18 of the bone plate 10 and the underlying bone portion in the region of the bend. The size of this gap may be reduced (optionally without eliminating the gap) in response to insertion of one or more screws and/or compression of the bone plate.

The bend 40 of the bone plate 10 may curve the distal region 20 toward the proximal region 24 about the intermediate region 28 . For example, the bend 40 can reduce the distance between the first end 22 and the second end 26 compared to if the body 12 were flat or planar. The bend 40 may be defined by a sharp transition (eg, a V-shape) or a radius of curvature. The radius of the bend 40 may vary or be constant as a function of longitudinal position on the body 12 and/or the radius of the bend 40 may vary or be constant as a function of longitudinal position on the body 12 and/or may be concentrated in one or more parts of the In some examples, bend 40 is defined by a radius of curvature ranging from about 10° to about 45°, such as from about 15° to about 35°. In other examples, bend 40 may be defined by a radius of curvature ranging from 45° to 135°, such as from about 75° to about 105°. Other bending angles are also possible.

If the bone plate 10 is configured with a bend, the entire length of the bone plate may be bent (e.g., to define a radius of curvature), or only one region of the bone plate may bend over the rest of the bone plate. It may be bent out of plane with respect to the portion. Thus, when describing that the bone plate 10 may have a bend 40 in the intermediate region 28 between the proximal region 20 and the distal region 24, the bend may be isolated relative to that region. Please understand that it does not have to be done. Rather, the bend 40 may define an apex in the intermediate region 28 between the first fixation hole 30 and the second fixation hole 34, e.g. such that the maximum offset for the fixation hole (and/or the first and second ends) is within this region. Depending on the application, the apex of the bend 40 may be placed along the length of the bone plate 10 such that when the bone plate is placed over a joint separating bone portions, the apex of the joint substantially centered above (eg, within ±3 mm of the joint, such as ±2 mm of the joint, or ±1 mm of the joint).

Bone plate 10 can be formed from any suitable biocompatible material or combination of materials, such as stainless steel, nitinol, titanium, and/or polymeric materials (eg, polyetheretherketone or PEEK). The bend 40 can be formed by manufacturing the bone plate 10 to include the bend (eg, by casting or machining a bone plate start that includes the bend 40). Alternatively, bone plate 10 may be made as a flat plate that is then bent (eg, plastically deformed) to create bend 40.

Bone plate 10 can have a variety of features and configurations. For example, the width of the bone plate 10 may be constant over the length of the bone plate, or such that one or more regions of the bone plate have a greater width than one or more other regions of the bone plate. May change. For example, in some implementations, bone plate 10 can have a greater width in regions that include fixation holes and a narrower width in regions between adjacent fixation holes. Additionally or alternatively, the thickness of bone plate 10 may be constant over the length of the bone plate, or one or more regions of the bone plate may be thicker than one or more other regions of the bone plate. It may also vary to have a greater thickness. For example, the bone plate 10 may include a pad that projects downwardly from the remaining portion of the bone-facing surface 18 (e.g., in the area of the fixation hole) and/or a channel that is recessed relative to the remaining portion of the bone-facing surface 18. Different thicknesses may be defined over the length of the plate. Exemplary bone plate features that may be used are described in U.S. Pat. No. 10,245,088, entitled "Bone Plating System and Method," the entire contents of which are incorporated herein by reference. It will be done.

Bone fasteners may be used to secure the bone plate 10 to the underlying bone portion. As briefly mentioned above, at least one of the bone fasteners used to secure the bone plate to the underlying bone portion achieves both engagement and compression with the bone plate, and The flexure 40 may be configured as a locking screw configured to deform the bend 40 toward the underlying bone surface.

FIG. 3 is a side view of an exemplary locking screw 50 that may be used with the bone plate 10 of FIGS. 1 and 2. FIG. Locking screw 50 extends from proximal end 52 to distal end 54 . Locking screw 50 includes a head 56 and a shaft 58. The head 56 of the locking screw 50 has a thread that partially or completely surrounds the head for engagement with a mating threading surrounding the fixation hole in the bone plate 10 into which the locking screw is intended to be inserted. Including 60. Thread 60 may be referred to as a head thread for purposes of explanation. The shaft 58 of the locking screw 50 includes threads 62 that partially or completely encircle the shaft for engaging the bone portion underlying the fixation hole of the bone plate 10 into which the locking screw 50 is inserted. . Threads 62 may be referred to as shaft threads for purposes of explanation.

Threads 60 and 62 may each be a helical structure used to convert rotational motion into linear motion or force. Threads 60 and 62 may be defined by a thread of material wrapped around an inner cylinder or cone of material in the form of a helix to define a straight thread or a tapered thread, respectively.

Locking screw 50 can be characterized by both lead and pitch. The lead is the distance along the axis of the screw covered by one complete revolution (360°) of the screw. Pitch is the distance from the top of one thread to the next thread. In some examples, locking screw 50 is configured as a single lead screw, such that there is only one thread wrapped around the body of the screw, for example. When configured in this manner, each revolution (360°) of the body of the screw advances it axially along the axis of the screw by a distance equal to the pitch or spacing between adjacent ridges. In other examples, the locking screw 50 is configured to advance axially by a multiple of the pitch or spacing between adjacent ridges with each revolution of the body of the screw, such as a double lead screw, a triple lead screw, Or configured as a multi-lead screw such as a quadruple lead screw. In other words, the pitch and lead may be equal for a single lead screw, but the lead may be the pitch or spacing between adjacent ridges multiplied by the number of threads for a multi-lead screw. (For example, pitch x2 for a double lead screw, pitch x3 for a triple lead screw).

According to some implementations of the present disclosure, locking screw 50 is configured to be inserted through the fixation hole of bone plate 10 and pushed into the underlying bone portion. The locking screw can be configured with a compression ratio greater than 1.0. As used herein, the term "compression ratio" means the pitch of the shaft threads multiplied by the number of threads of the shaft threads, the sum of which is equal to the pitch of the head threads. Divided by the head screw thread. This can be expressed as:

In practice, the head thread 60 may typically be a single thread. In such a configuration, if the shaft threads 62 define a single thread, the compression ratio may be the pitch of the shaft threads 62 divided by the pitch of the head threads 60. If the shaft threads 62 define a double start thread, the compression ratio may be twice the pitch of the shaft threads 62 divided by the pitch of the head threads 60.

The differential pitch and/or thread between head threads 60 and shaft threads 62 is effective to deliver a compressive force to bone plate 10 when locking screw 50 is inserted into the bone plate. may be selected to be. For example, when bone plate 10 is secured to one bone segment with a bone fastener, locking screw 50 may be inserted into another bone segment through the fixation hole across the joint. When the head threads 60 of the locking screw 50 engage the mating threads surrounding the fixation hole in the bone plate into which the screw is inserted, the shaft threads 62 continue to draw the screw into the underlying bone. Can be done. As a result, the bending portion 40 of the bone plate 10 may deform by bending toward the bone portion. As the locking screw 50 continues to be screwed into the fixation hole of the bone plate 10, the bending portion 40 may further deform. Locking screw 50 may be inserted into the underlying bone until head 56 is fully seated within the receiving opening defined by the fixation hole in the bone plate.

The particular compression ratio effective to achieve compression of bone plate 10 during use may vary based on, for example, the thickness of the plate. Generally, the compression ratio may be greater than 1.0. As a result, one rotation (360°) of the locking screw 50 moves the screw through a greater axial distance than the axial distance traveled by the head of the screw seated within the mating thread defined by the locking hole. can be traversed by the shaft of As a result, the bone plate 10 can deform a distance towards the underlying bone into which the locking screw 50 is inserted to accommodate the difference in the length of movement of the shaft relative to the head due to the compression ratio. .

FIG. 3 shows a head 56 with an exemplary pitch 64 and a shaft 58 with an exemplary pitch 66. The compressive force generated by having different pitches and/or thread numbers between the head and the shaft can be characterized by the compression ratio as described above. In some implementations, the locking screw 50 is greater than 1.0, such as greater than 1.5, such as greater than 1.6, greater than 1.7, greater than 1.75, greater than 1.9. , greater than 2.1, greater than 2.3, greater than 2.5, or greater than 3.0. For example, the compression ratio of the locking screw 50 may be within the range of 1.45 to 3.5, such as 1.5 to 2.5. A locking screw exhibiting the aforementioned compression ratio may be effective to deform the bend 40 of the bone plate 10, such that the bone plate has a thickness of less than 5 mm, such as less than 3 mm, or less than 2 mm in the area of the bend. has. For example, the bone plate 10 may have a thickness in the range of 1 mm to 2 mm (eg, at least in the region of the bend 40) and may be deformed by a locking screw having a compression ratio greater than 1.5. good. In some implementations, the locking screw having any one of the aforementioned compression ratios has a single head thread such that the compression ratio is provided by the shaft threads having a larger pitch than the head threads. and a single threaded shaft.

The bone plate 10 includes at least one fixation hole extending through the body 12 at a distal region 20 of the bone plate and at least one fixation hole extending through the body and proximal region 24 of the bone plate. Can be done. In use, at least two fixation elements can be used to fix the bone plate to two different bone parts, for example, the intermediate region 28 of the bone plate bridges the joint or gap between the two bone parts. can do. For example, as described with respect to FIGS. 1 and 2, the bone plate 10 can include at least a first fixation hole 30 and a second fixation hole 34, with the second fixation hole 34 in the illustrated example. , a third fixing hole 32 and a fourth fixing hole 36. Bone plate 10 may be configured, for example, using a single locking screw configured as described with respect to FIG. A locking screw can be used to engage the underlying bony portion. Lower the bone plate using at least one locking screw configured with a high compression ratio, such as a compression ratio greater than 1.5 (e.g., at least two locking screws so configured). It can be fixed to certain bone parts. One or more other fixation elements having a different configuration than the enhanced compression ratio locking screw 50 may be inserted through other fixation holes in the bone plate. When two or more locking screws 50 are used, the two or more locking screws may have the same configuration as each other (e.g., the same compression ratio) or locking screws as described herein. It may have a different configuration (eg, a different compression ratio) that still matches the set screw 50.

A bone plate fixation system including bone plate 10 includes at least one locking screw 50 (e.g., two, three, or four) that exhibits a compression ratio effective to deform bone plate bend 40 during use. (such as a locking screw 50). The bone plate fixation system includes one or more other mechanical fixations having a different configuration than the locking screws 50 that are insertable through other fixation holes in the bone plate to complete the attachment to the underlying bone portion. Can contain elements. Any suitable fastening elements such as screws, pins, rivets, spikes, etc. having a different configuration than locking screws 50 may be used for these other attachment elements.

For example, the bone plate fixation system includes at least one locking screw 50 that exhibits a compression ratio effective to deform the bend of the bone plate 10 during use and a compression ratio that is less than the compression ratio of the locking screw 50. and at least one other screw (eg, two, three, four, or more) that is a non-locking screw and/or a locking screw as shown. For example, a bone plate fixation system can include one or more locking screws having a compression ratio of less than 1.5, such as less than 1.45, less than 1.25, or less than 1.2. For example, the bone plate fixation system has a compression ratio that is at least less than the compression ratio exhibited by locking screw 50 configured as described with respect to FIG. One or more locking screws having a compression ratio as low as 0.05 may be included. In some examples, the bone plate fixation system may include one or more locking screws with a compression ratio of 1.0.

In one implementation, the bone plate fixation system includes a bone plate 10 and at least two locking screws 50 that exhibit a compression ratio effective to deform a bend 40 within the bone plate; (e.g., compression ratios that do not result in substantial bending or any bending of the bone plate). In these systems, at least one locking screw 50 may be installed through the fixation hole on the distal region 20 of the bone plate 10 and at least one locking screw 50 may be installed on the proximal region 24 of the bone plate. may be installed through the fixing hole. In these examples, at least one or two other locking screws having a lower compression ratio than locking screw 50 are inserted through the remaining fixation holes on the distal region 20 and/or proximal region 24 of the bone plate. may be installed.

FIG. 4 shows a bone plate 10 secured to a first bone portion 70 and a second bone portion 72 at a separation 74 between the two bone portions (referred to herein as a “joint 74” for purposes of explanation). FIG. The first bone portion 70 and the second bone portion 72 may be different portions of the same bone (e.g., a metatarsal), in which case the separation 74 is at the cutting line between the two bone portions. (eg, if an osteotomy or bone shortening procedure has been performed) or a fracture. Alternatively, the first bone portion 70 and the second bone portion 72 may be different bones, in which case the separation portion 74 is a metatarsal and a cuneiform separated by the tarsometatarsal joint. It may be a joint such as. In the particular example of FIG. 4, first bone portion 70 is shown as a metatarsal and second bone portion 72 is shown as a cuneiform.

Note that references to different features or elements in this disclosure as first, second, third, etc. are for convenience only and are not intended to impose an order of operation unless otherwise specified. I want to be understood. For example, bone plate 10 may include a first fixation hole 30 positionable over first bone portion 70 and a second fixation hole 34 positionable over second bone portion 72. Although described, it should be understood that in different examples, the first bone portion may be a metatarsal or a cuneiform. Furthermore, during installation, the initial screw may be placed through the second fixation hole 34 instead of the first fixation hole 30. Accordingly, other orders of installation and arrangement of components may be used and should not be limited to the particular examples described.

In the example of FIG. 4, the bone plate 10 is positioned over a first bone portion 70 (e.g., a metatarsal) underlying a first fixation hole 30 and a third fixation hole 32, and a second Fixation hole 34 and fourth fixation hole 36 are shown bridging across joint 74, with fixation hole 34 and fourth fixation hole 36 positioned over an underlying second bone portion 72 (eg, cuneiform). The bone plate 10 uses at least one locking screw 50 and at least one other fixation element that is not configured as a locking screw 50 (e.g., a non-locking screw or a locking screw with a lower compression ratio). When installed, at least one locking screw can be inserted through any one of the fixation holes in the bone plate. However, in some implementations, the locking screw 50 may be installed through one or both fixation holes closest to the joint 74 separating the two bone portions.

For example, when configured as shown in FIG. 4, one locking screw 50A may be installed through the first fixing hole 30, and/or one locking screw 50B It may also be installed through the hole 34. The locking screws 50A, 50B may exhibit a compression ratio effective to deform the plate 10 at least in the region of the bend 40. Utilizing one or more locking screws having a relatively high compression ratio through one or more fixation holes proximal to the intermediate region 28, including the apex of the bend 40, may, for example, cause the bone plate to be desirably deformed. By delivering compression closest to the location, it may be useful to help deform the bend toward the underlying bone surface.

One or more other fixation holes in bone plate 10, such as one or more fixation holes located proximally and/or distally of the fixation hole closest to intermediate region 28, are connected to locking screws 50A, 50B. may be secured to the underlying bone portion using screws with different configurations. For example, one locking screw 76A may be installed through the third securing hole 32 and/or one locking screw 76B may be installed through the fourth securing hole 36. Locking screws 76A, 76B may exhibit a lower compression ratio than each of locking screws 50A and 50B (eg, when at least two locking screws 50 are utilized).

A non-planar bone plate, such as bone plate 10 having bends 40, and one or more engagements capable of engaging the bone plate and generating compressive forces sufficient to deform the non-planarity of the bone plate during installation. A bone plate fixation system including set screw 50 may be useful to help compress bone portions that are secured together using a bone plate. Bone plate 10 is initially attached to two bones with distal region 20 at least partially contacting first bone portion 70 and proximal region 24 at least partially contacting second bone portion 72 . When placed over a joint separating the portions, a gap may exist between the bone-facing surface of the bone plate and the underlying bone portion. When one or more locking screws 50 are installed into the underlying bone through one or more corresponding fixation holes in the bone plate 10, the flexure 40 is directed toward the underlying bone portion (e.g. , plastically and/or elastically). This can create a residual spring force that compresses the ends of the bone parts together. For example, physically compressing the flexure 40 from an initial apex height to a reduced apex height can place the top side of the bone plate in compression and the bottom side of the bone plate in tension; This creates a moment force with an asymmetrically distributed magnitude across the end face of the bone. In implementations where the bone plate system is applied dorsally to two bone portions (e.g., across the metatarsophalangeal joint or across the tarsometatarsal joint), this applies to the distal bone portion relative to the proximal bone portion. The portion may tend to plantarflex, thereby compressing the epiphyses across the joint to promote healing (eg, fusion) and augment joint realignment performed prior to fixation.

5 and 6 illustrate an exemplary application of bone plate 10 using first and second locking screws 50A, 50B. FIG. 5 shows a joint 74 (e.g., a 1 shows a bone plate 10 placed over the tarsometatarsal joint. FIG. 6A shows the bone plate 10 after installation of the first and second locking screws 50A, 50B. FIG. 6B is a force diagram schematically illustrating an exemplary distributed load that may be applied across a joint by bone plate 10 after deformation. The bone plate 10 of FIG. 5 is shown with an optional drill guide threaded into the fixation hole of the bone plate.

During installation, bone plate 10 may be placed over joint 74, for example, with the apex of bend 40 substantially centered over the joint. The first fixation hole 30 may be placed over the underlying first bone portion 70 and the second fixation hole 34 may be placed over the underlying second bone portion 72. good. For example, the distal region 20 may at least partially contact the first bone portion 70, the proximal region 24 may at least partially contact the second bone portion 72, and the flexure 40 is raised above the surface of one or both bone parts. As a result, a gap 80 may exist between the bone-facing surface 18 of the bone plate 10 and the juncture defined by the end of the bone below the bend 40. The size of the gap 80 may vary, for example, depending on the extent of the bend 40, and in some examples at least 1 mm, such as at least 1.5 mm, at least 1.75 mm, at least 2 mm, at least 2.25 mm. , at least 2.5 mm, at least 3 mm, at least 3.5 mm, at least 4 mm, or at least 5 mm.

The clinician attaches the bone plate 10 to the first and second bone portions 70, 72 by inserting one or more locking screws 50A, 50B into one or more corresponding fixation holes in the bone plate. Good too. For example, the clinician may insert the first locking screw 50A through the first fixation hole 30 and thread the locking screw into the underlying first bone portion 70. The clinician tightens the first locking screw 50A until the head threads on the locking screw partially, but not completely, engage the mating threads extending around the first fixation hole 30. Advancement may continue (eg, such that the head thread on the locking screw partially engages the mating thread but can continue to be advanced downwardly relative to the mating thread). If the opposite side of the bone plate 10 is already secured to the second bone portion 72 using fixation elements, the clinician may further screw the first locking screw 50A into the first bone portion 70. can. After the head thread of the locking screw initially engages the mating thread on the fixation hole, as the shaft thread of the first locking screw 50A advances downwardly into the first bone portion 70. , the compression ratio provided by the differential configuration of the head and shaft threads may generate a compressive force that deforms the flexure 40 toward the joint 74.

Depending on the sequence of operations, before or after installing the first locking screw 50A in the first bone portion 70, the clinician inserts the second locking screw 50B through the second fixation hole 34; A locking screw can be screwed into the underlying second bone portion 72. The clinician advances the second locking screw 50B until the head threads on the locking screw are partially or fully engaged with the mating threads extending around the second locking hole 34. (e.g., the head thread on a locking screw may be partially engaged with the mating threading but continue to be advanced relative to the mating threading, or may be completely engaged with the mating threading. (like sitting down). The clinician can further screw a second locking screw 50B into the second bone portion 72. After the head thread of the locking screw first engages the mating thread on the fixation hole, the shaft thread of the second locking screw 50B is advanced downwardly into the second bone portion 72. As such, the compression ratio provided by the differential arrangement between the head and shaft threads may generate a compressive force that causes the flexure 40 to deform toward (eg, further deform) the joint 74.

As the bend 40 of the bone plate 10 deforms toward the opposing surface of the underlying bone portion and/or joint 74, the bend may flatten. For example, if the flexure 40 is characterized by a radius of curvature, the radius of curvature is smaller after installation when the flexure is undeformed (FIG. 5) compared to before installation; (Fig. 6A) may be larger. In some installations, the bend 40 of the bone plate 10 extends over the facing surface of the underlying bone portion until the bone-facing surface of the bone plate contacts the bone portion in an area that formally defines the apex of the bend. bent downwards towards. In other installations, such as that shown in FIG. 6A, the bend 40 of the bone plate is bent toward the opposing surface of the underlying bone portion, but between the bone-facing surface 18 of the bone plate 10 and the bend 40 below. A residual gap 80 remains between the joint line defined by the bone ends. In some examples, the size of gap 80 after installation of bone plate 10 is even less than 2 mm, such as less than 1.75 mm, less than 1.5 mm, less than 1 mm, less than 0.75 mm, or less than 0.5 mm. good.

As shown in FIGS. 5 and 6, the first fixation hole 30 and the second fixation hole 34 are arranged such that axes extending through the geometric center of each fixation hole converge to define a convergence angle 90. , may be oriented with respect to each other. After installing the screws through the first fixation hole 30 and the second fixation hole 34, the angle 90 may decrease, representing a flattening of the bend 40. However, the first and second fixing holes and correspondingly the first and second screws passing through the fixing holes may be inclined at converging angles with respect to each other. This may be useful to help generate a force that forces the end of the first bone portion 70 against the end of the second bone portion 72, the force being on the side on which the bone plate 10 is placed. has a distributed size that is larger on the opposite side of the bone part (eg, the cortex on the opposite side of the bone part) and smaller on the side where the bone plate is placed.

In some examples, the difference between the pre-deformation angle 90 minus the post-deformation angle 90 is 90 degrees or less, such as 60 degrees or less, 45 degrees or less, 30 degrees or less, or 20 degrees or less. For example, the angle 90 before deformation may range from 15 degrees to 90 degrees, for example from 20 degrees to 45 degrees. After deformation, angle 90 may range from 0 degrees to 45 degrees, such as from 5 degrees to 15 degrees. In one particular example, angle 90 may be within the range of 20-30 degrees before deformation and may be within the range of 5-15 degrees after deformation.

When the bends or arches of the bone plate 10 are physically deformed toward a flattened or non-bend profile (e.g., complete flattening of the plate, or residual bends or arches that are lower in height after deformation) ), the lower side of the plate can be placed under tension and the upper side of the plate can be placed under compression. As a result, a moment force can be applied that has an asymmetrically distributed magnitude across the end surface of the bone being compressed. FIG. 6B shows an exemplary triangular distributed load profile that may be generated across the end surface of a bone portion by deformation of a bone plate. The asymmetrically distributed forces that press the end surfaces of the bone portions together may be applied on the side of the bone portion opposite to the side that is in contact with the bone plate 10 (e.g., the cortex), and on the side of the bone that is not in contact with the bone plate. It may be larger than the side of the part (eg, the cortex). FIG. 6B shows an exemplary asymmetric force distribution with force vectors 92 of different magnitudes across the depth of the joint between two bone segments.

Features described as threads, including locking screw 50, may be made of any suitable biocompatible material or materials, such as stainless steel, nitinol, titanium, and/or polymeric materials (e.g., polyetheretherketone or PEEK). Can be formed from a combination. The threads may be uniaxial and/or polyaxial. Furthermore, the screws may be cannulated or non-cannulated and/or self-tapping or non-self-tapping. In some examples, one or more of the screws are cannulated (eg, all of the screws). In other examples, one or more of the screws are not cannulated (eg, all of the screws).

The screws, including locking screws 50, and bone plate 10 may be sized based on the desired use of the plate fixation system. In some examples, each screw used with bone plate 10 is sized to be inserted into a metatarsal and/or cuneiform of a human foot. For example, each screw may have a length in the range 8mm to 18mm, such as 10mm to 16mm, or 12mm to 14mm. If screws are provided that are intended to be inserted into both the metatarsals and cuneiforms, the screws may be the same size or one may be longer than the other (e.g. 1 mm, 2 mm , or more). The diameter of the screw shaft may vary, but in some examples the diameter ranges from 2 mm to 4 mm, such as from 2.5 mm to 3.2 mm.

FIG. 7 is a flow diagram illustrating an exemplary technique for installing a bone plate system according to the present disclosure. The technique of FIG. 7 includes performing an optional bone repositioning procedure to realign the first bone portion 70 with respect to the second bone portion 72; is fixed using a bone plate system (100). The bone realignment procedure may include realigning the metatarsals relative to the cuneiform, for example, realigning the first metatarsal relative to the medial cuneiform, or other It may also include realigning the bone portions with respect to each other. For example, repositioning procedures may include the second metatarsal relative to the intermediate cuneiform, the third metatarsal relative to the lateral cuneiform, and the proximal phalanx relative to the metatarsal across the metatarsophalangeal joint. or may further include realigning other bone portions with respect to each other.

For example, to correct the alignment of a first bone portion (e.g., a metatarsal) relative to a second bone portion (e.g., a cuneiform), a clinician may perform a surgical procedure on the joint between the two bone portions. can be accessed. Once accessed, the clinician may prepare the end surfaces of the two bone sections. The clinician can prepare the ends of each bone to promote fusion of the epiphyses across the joint following realignment. Bone preparation may include using a tissue removal instrument to apply force to the end surface of the bone to create a bleeding bone surface to promote subsequent fusion. Exemplary tissue removal instruments that may be used include, but are not limited to, saws, rotary drilling instruments, bone forceps, reamers, osteotomes, sharpeners, and the like. The tissue removal instrument may be applied to the end surface of the bone being prepared to remove cartilage and/or bone. For example, a tissue removal instrument can be applied to the end surface to remove cartilage (eg, all cartilage) down to the subchondral bone. Additionally or alternatively, the tissue removal instrument may be used to cut, fenestrate, mortarize, and/or otherwise reshape the end surfaces of the bone and/or to promote fusion of the bleeding bone. It may be applied to form a surface. When a cutting operation is carried out to remove the end of a bone, this cutting is carried out free-hand, with the help of a cutting guide having a guide surface positionable over the part of the bone to be cut. may be implemented. When using a cutting guide, a cutting instrument may be inserted against a guide surface (eg, between a slot defined between two guide surfaces) to guide the cutting instrument for bone removal.

Either before or after preparing one or both ends of the bone segments, the clinician connects one bone segment (e.g., a metatarsal) with a bone segment (e.g., a first metatarsal). in at least one plane, such as at least the transverse plane to close the intermetatarsal angle between adjacent bones (e.g., the second metatarsal), and/or in the coronal plane to reduce the sesamoid bones. It may be moved within the In some examples, the clinician moves the bone portion in multiple planes, such as a transverse plane and/or a coronal plane and/or a sagittal plane. The clinician may or may not utilize a bone placement guide to facilitate movement of the bone portion. Once the bone portion is moved to the desired location, the clinician optionally temporarily fixes the moved location (e.g., by inserting a k-wire through the moved bone portion and into an adjacent bone portion). , the displaced position can then be permanently fixed using one or more bone plate systems as described herein. Details of exemplary bone repositioning instruments and techniques that can be used in conjunction with the present disclosure are provided in U.S. Pat. , 622,805, the entire contents of which are incorporated herein by reference.

In some applications, regardless of whether the clinician performs the particular bone repositioning technique described above, the clinician may perform a first One bone portion 70 is temporarily or temporarily fixed to a second bone portion 72. The clinician may compress the first bone portion 70 and the second bone portion 70 by, for example, manual pressure and/or using a compression instrument physically attached to both the first bone portion 70 and the second bone portion. The end surfaces of the bone portions 72 may be pressed together. For example, a clinician may attach a compression device to a first bone portion 70 using one or more fixation pins, and a compression device to a second bone portion using one or more fixation pins. May be attached. The compression device may have a mechanism (eg, a threaded rod, rack and pinion) that pushes a pin inserted through the two bone sections to compress the end surfaces of the two bone sections together. Additional details regarding exemplary compressor structures that may be used in accordance with this disclosure may be found in U.S. Patent Application Publication No. 2020/0015856, filed January 16, 2020 and entitled "COMPRESSOR-DISTRACTOR FOR ANGULARLY REALIGNING BONE PORTIONS." No. 1, the entire contents of which are incorporated herein by reference.

In some implementations, the clinician inserts one or more fixation pins through the end surfaces of the first bone portion 70 and the second bone portion 72 in addition to or instead of compressing the end surfaces with a compression instrument. Insert. The fixation pin may be a k-wire, olive wire (eg, a pin with an enlarged cross-sectional area), or other fixation pin structure. The fixation pin cross joint 74 between the first bone portion 70 and the second bone portion 72 is inserted into the second bone portion prior to placement of the bone plate 10 for infiltration fixation (and subsequent fusion of the bone surfaces together). can help temporarily fix and/or compress the end surfaces of two bone segments. When used, the one or more fixation pins may be used after the bone plate 10 is installed (e.g., at least one fixation element is placed through the bone plate and into each of the first bone portion 70 and the second bone portion 72). ) can be removed from the end faces of the two bone parts and across the joint between the bone parts.

Still referring to FIG. 7, the exemplary technique includes placing a bone plate 10 across a joint separating two bone portions (102). The bone plate 10 can include a first fixation hole 30, a second fixation hole 34, and a bend 40 between the first fixation hole and the second fixation hole. Placing the bone plate across the joint may include, for example, placing the bone plate over the joint with the distal region 20 of the bone plate contacting a first bone portion and the proximal region 24 of the bone plate contacting a second bone portion. It may also involve positioning the bend 40 thereon. As a result of the presence of the bend, a gap 80 may exist between the bone-facing surface 18 of the bone plate and the underlying surface and/or the articulation of the epiphysis.

The technique of FIG. 7 may also include inserting locking screw 50 through the first fixation hole of bone plate (104). The locking screw 50 can have a head with head threads and a shaft with shaft threads. The shaft threads may be configured to provide a compression ratio greater than 1.0, such as greater than 1.5, relative to the head thread. The head threads may be configured (e.g., sized and/or shaped) to engage corresponding mating threads surrounding the first fixation hole. The clinician locks the locking screw through the first locking hole by advancing the distal end of the screw through the opening defined by the first locking hole and beginning to thread the shaft of the locking screw into the underlying bone. A set screw may be inserted. In different examples, the holes may or may not be pre-drilled into the bone prior to insertion of the screw.

With the distal end of locking screw 50 inserted through the first fixation hole of bone plate 10, the clinician can screw the locking screw into the underlying bone (106). Manipulating with hand force or with the aid of a rotary drilling instrument, the clinician rotates the locking screw 50 in either a clockwise or counterclockwise direction (depending on the thread pattern). , the screw can be advanced axially downward into the bone portion below the fixation hole in the bone plate. The clinician can continue to screw the locking screw 50 and advance the screw axially into the bone portion. When the head threads on the head of the locking screw contact the mating threads surrounding the first fixing hole, the head threads interleave with the mating threads surrounding the first fixing hole, thereby , may engage a thread.

With the head screw thread at least partially engaged with the mating thread defined by the first fixation hole, the technique of FIG. Including further screwing. When the bone plate 10 is already secured to other bone portions across the joint, further rotation of the locking screw 50 may deform the bone plate (eg, the bend 40 of the bone plate). Bone plates can deform by bending toward the joint and underlying bone.

Before and/or after placing locking screw 50 through the first fixation hole of the bone plate, the clinician installs one or more locking screws, such as one or more locking screws, through one or more additional fixation holes of the bone plate. Fixed elements can be installed. For example, before or after placing the locking screw 50 into the first bone portion through the first fixation hole, the clinician installs another locking screw 50 into the second bone portion through the second fixation hole. (which may or may not have a relatively high compression ratio) may be installed. The clinician inserts one or more additional locking screws (with or without relatively high compression ratios) through other fixation holes in the bone plate, such as the third fixation hole and the fourth fixation hole. One or more additional screws may be installed, such as a

As described herein, a bone plate fixation system applied across a joint separating the ends of two bone segments compresses the end surfaces of the two bone segments together to promote fusion. Can assist. In some instances, plate fixation systems produce asymmetric compression where the distal cortex of the epiphysis is more compressed than the proximal cortex. In some applications, such as when a bone plate is applied to the dorsal surface of a bone segment, this will plantarflex the realigned bone segment and enhance corrective realignment in the sagittal plane while facilitating fusion. can help you. Additionally, or alternatively, when a bone plate is applied to the medial surface of the bone segment, it biases the realigned bone segment laterally, promoting corrective reorganization in the transverse plane. It may help to reinforce alignment (eg, bias the intermetatarsal angle closed).

A variety of different instruments and additional or alternative techniques can be used to facilitate installation of bone plate fixation systems as described herein. For example, one or more drive pins (eg, plate tuck pins, drill pins) may be used to help facilitate placement of bone plate 10. When used, the drive pin can be inserted through the fixation hole in the bone plate and into the underlying bone. In some examples, the drive pin includes a threaded distal region and can be rotationally driven into the underlying bone by threading. In either case, the drive pin can enter or drill a hole in the bone part below the fixation hole into which the drive pin is inserted.

In some implementations, the drive pin may include an enlarged region having a larger cross-sectional area than the cross-sectional area of the fixation hole. As the drive pin is advanced into the underlying bone, the region of larger cross-sectional area extends relative to the upper side of the bone plate 10 (e.g., directly against the upper side or above the upper surface). (either indirectly via the drill guide). Continued rotation of the drive pin may deform the flexure 40 by causing the enlarged cross-sectional area to compress the flexure toward the surface of the underlying joint and/or bone portion. As a result, the bone plate can be partially or completely deformed by the drive pin towards the desired degree of compression. The drive pin can then be removed from the fixation hole and the locking screw inserted through the fixation hole and into the underlying bone. Another fixation device (e.g., pin, screw, etc.) is placed on one or more adjacent Can be placed through the hole.

When the bone plate 10 is pre-deformed using a drive pin prior to the installation of one or more screws, the screws used to secure the bone plate to the underlying bone portion are relatively high. A locking screw 50, which exhibits a compression ratio, may or may not be included. In some applications that use drive pins for pre-deformation, at least one (and optionally all) fixation elements used to secure the deformed bone plate to the underlying bone are lower With non-locking screws or locking screws configured with a compression ratio (e.g., a compression ratio of less than 1.5, or one that is not effective to substantially deform the plate during installation, such as a compression ratio of 1.0). There may be. However, in some implementations, locking screws 50 with increased compression ratios (e.g., one or both proximal to joint 74) are used to help secure the bone plate to the underlying bone portion. (through the fixing hole).

FIG. 8 is a side view of an exemplary drive pin 120 that can be used to help attach a bone plate to bone. For example, drive pin 120 may be connected to a driver (e.g., an impact driver, rotary driver, drill) that uses drive pin 120 to apply force to drill into the bone underlying the bone plate. . Additionally or alternatively, a clinician utilizing drive pin 120 can apply force through a manual instrument to drive the drive pin. In either case, after the drive pin 120 is used to create the hole and/or orient the bone plate, the drive pin can be removed from the bone and bone plate. A bone fixation member (eg, a bone screw) can then be inserted into the opening formed by drive pin 120 to permanently retain the bone plate to the bone.

In the illustrated example, drive pin 120 defines a body that extends from proximal end 122 to distal end 124 . The body defines a plurality of regions of different cross-sectional thickness, and in the illustrated example is shown as at least three regions of different cross-sectional thickness. For example, the body of the drive pin 120 defines a bone-penetrating region 126 adjacent the distal end, a drive region 128 adjacent the proximal end, and a bone plate orientation region 130 between the bone-penetrating region and the drive region. You may. Bone penetrating region 126 can have a smaller cross-sectional thickness than bone plate orientation region 130. Bone plate orientation region 130 may have a smaller cross-sectional thickness than drive region 128, or in other implementations may have the same or greater cross-sectional thickness as drive region 128.

Configuring drive pin 120 with multiple cross-sectional thicknesses may be useful to provide different functionality while limiting unnecessary trauma to the bone with which the drive pin is engaged. For example, the bone penetrating region 126 can be sized relatively small to minimize bone damage and facilitate insertion of the distal end of the drive pin. Bone plate orientation region 130 may be sized to be complementary to the diameter of the fixation hole in the bone plate into which the drive pin is inserted. This can provide a close fit between the drive pin and the bone plate, for example, to precisely rotate the bone plate around the drive pin to orient the bone plate during installation. Drive region 128 may be larger sized for engagement with drivers used in the process. In some configurations, drive pin 120 is provided as part of a kit that includes other drive devices (e.g., pins, k-wires) and is connected to other drive devices to provide uniform drive connection size across the devices. having the same diameter as one or more of the instruments. In other words, drive pin 120 may be part of a kit with one or more (and optionally two or more) other instruments (e.g., all components of the kit are housed within a sterile case). (if included), each instrument has a shaft of substantially the same diameter and each instrument is configured to couple to the same driver for driving the instrument.

As shown in FIG. 8, the bone-penetrating region 126 may be threaded to facilitate rotational drive (threading) of the drive pin into the underlying bone. When threaded, the threading on the bone-penetrating region 126 may be any suitable pitch that may be the same or different than the pitch on the shaft threads of the locking screw 50 that may be inserted through the fixation hole after removal of the drive pin. A pitch may be defined. The distal end 124 of the drive pin 120 may have a trocar or other tip (eg, a self-tapping tip) for initiating penetration of the drive pin 120 into the underlying bone.

Although drive pin 120 is shown to include a threaded bone-penetrating region 126 and an unthreaded plate orientation region 130, the drive pin need not have two distinct regions. Rather, if bone penetrating region 126 and plate orientation region 130 are configured with the same cross-sectional size, the threading may optionally extend to also include the region of the drive pin that serves as the plate orientation region.

Generally, drive pin 120 can have any desired cross-sectional shape, including polygonal shapes, arcuate shapes, and combinations thereof. In some configurations, at least the bone penetrating region 126, drive region 128, and bone plate orientation region 130 of the drive pin have a circular cross-sectional shape.

Drive pin 120 has a variety of different sizes, but in some examples, bone penetrating region 16 has a diameter ranging from 0.1 mm to 2 mm, and/or bone plate orientation region 130 has a diameter ranging from 0.5 to 3 mm. and/or the drive region 128 has a diameter in the range of 1.6 mm to 3.7 mm. For example, bone penetrating region 126 may have a diameter ranging from 1 mm to 2 mm, and bone plate orientation region 130 may have a diameter ranging from 1 mm to 2 mm.

Drive pin 120 can have one or more regions of different cross-sectional thickness than bone-penetrating region 126, drive region 128, and bone plate orientation region 130. For example, in the illustrated example, drive pin 120 includes a fourth region 132 of greater cross-sectional thickness than at least bone-penetrating region 126 and bone plate orientation region 130. In the illustrated configuration, fourth region 132 also has a greater cross-sectional thickness than drive region 128. The fourth region 132 is disposed proximal to the bone plate orientation region 130 and has a cross-sectional thickness that is greater than the bone plate fixation hole diameter and/or the cross-sectional thickness of the drill guide into which the drive pin 120 is configured to be inserted. can have. Fourth region 132 can function as a feature to limit the downward insertion depth of drive pin 120 when drive pin 120 is being inserted through the bone plate and/or drill guide. If included, the fourth region 132 may be integral (e.g., permanently formed) with the remainder of the drive pin body or may be a multi-piece assembly separately attachable to the drive pin. It may be part of.

Fourth region 132 can have any desired cross-sectional shape (e.g., circular, spherical, rectangular, triangular, oval), where the cross-sectional shape is the same as the cross-sectional shape of an adjacent section of the drive pin. may also be different. In some examples, fourth region 132 has a cross-sectional thickness in the range of 1.5 mm to 12 mm, such as 2 mm to 5 mm. Further details regarding exemplary drive pin techniques and devices that may be used can be found in MULTI-DIAMETER BONE PIN FOR INSTALLING AND ALIGNING BONE FIXATION PLATE WHILE MINIMIZING, filed July 12, 2019. The United States titled “BONE DAMAGE” Patent Application Publication No. 2020/0015870, the entire contents of which are incorporated herein by reference.

FIG. 9 is a side view of the bone plate 10 showing the drive pin 120 inserted through the second fixation hole 34 of the bone plate. In the illustrated configuration, drill guide 140 is screwed into a threaded opening defined by the fixation hole. As shown in this example, the threads surrounding the bone-penetrating region are the same when the drive pin is fully inserted and the enlarged region abuts the drill guide (or, in other configurations, the top surface of the bone plate itself). terminating at the proximal end in front of where the drive pin intersects the bone plate.

10-15 are perspective views illustrating example procedural steps that may be used to install a bone plate on two bone segments separated by a joint, in accordance with the present disclosure. In particular, FIGS. 10-15 illustrate, for example, preparing the ends of two bones, repositioning the first metatarsal relative to the cuneiform, and/or temporarily fixing the bone portions together. Exemplary procedural steps are shown for attaching bone plate 10 to medial cuneiform bone 70 and first metatarsal bone 72 separated by the tarsometatarsal joint.

As shown in FIG. 10, bone plate 10 may be placed over the tarsometatarsal joint separating metatarsal bone 72 from cuneiform bone 70. As shown in FIG. In the orientation shown, the bone plate 10 is placed on the dorsal sides of two bones (eg, the most dorsal half, the most dorsal quarter). In other applications, the bone plate 10 is placed on the surfaces of two bones, such as on the medial sides of the two bones (e.g., the innermost halves, the innermost quarters), and/or the dorsal medial side of the two bones. It may also be located at other locations along the line.

Continuing to refer to FIG. 11, the first drive pin 120A may be inserted through the first fixation hole 30 located proximate to the area of the bone plate 10 that defines the apex of the bend. The drive pin 120A can be rotationally driven into the underlying bone (cuneiform 70) through the first fixation hole. As the drive pin drills axially into the bone, an enlarged region of the drive pin can contact a top surface of the bone plate (eg, a top surface of a drill guide that extends above the bone plate). Continued rotation of drive pin 120A causes the enlarged region of the drive pin to press against the bone plate, at least partially deforming the bend by compressing the bend, resulting in a relative flattening of the bone plate. Can be done.

As shown in FIG. 12, a second drive pin 120B may be inserted through a second fixation hole 34 located on the opposite side of the joint from the first drive pin 120A. The second fixation hole 34 may be located closest to the region of the bone plate 10 that defines the apex of the bend opposite the first fixation hole 30 . The second drive pin 120B can be rotationally driven into the underlying bone (metatarsal bone 72) through the second fixation hole. Again, as the drive pin drills axially into the bone, the enlarged region of the drive pin can contact the top surface of the bone plate (e.g., the top surface of a drill guide extending above the bone plate). . Continued rotation of the drive pin 120B can force the enlarged region of the drive pin against the bone plate, further deforming the bend in the bone plate that was initially deformed upon insertion of the first drive pin 120A. . Full insertion of second drive pin 120B may complete deformation of bone plate 10 to the desired degree of compression.

To hold the bone plate 10 for screw insertion, a third fixation pin 150 is inserted into a fixation hole in the bone plate adjacent to the fixation hole into which the screw is desirably inserted, as shown in FIG. obtain. In this example, the third fixation pin 150 is inserted into the underlying bone through the third fixation hole 32 of the bone plate 10. The third fixation pin can be configured similarly to the drive pin 120, or it can be a different configuration of a pin, such as an olive drive threaded plate tack, or other pin. A third fixation pin 150 can be applied to hold the deformation and compression of the bone plate 10 (and the position of the bone plate). In other examples, the technique may proceed without installing the third fixation pin 150. The first drive pin 120A may be removed, but the second fixation pin 120B (or the screw through the opposite fixation hole) remains in place.

In either case, the first drive pin 120A can be removed from the first fixing hole 30 to open the fixing hole for installing a locking screw, as shown in FIG. After the first drive pin 120A is removed, a locking screw 50 (or other type of fixation element as described herein) is inserted through the first fixation hole 30 into the underlying bone. Can be screwed.

To secure the bone plate 10 to the cuneiform bone 70, the third fixation pin 150 (if used) is removed from the cuneiform bone with the locking screw 50 installed through the first fixation hole 30. can be done. Additionally, the second drive pin 120B can be removed from the metatarsal bone 72 and screws can be screwed into the second fixation holes 34 to secure the bone plate to the metatarsal bone. The screw inserted through the second fixation hole 34 can be a locking screw 50 or a different type of thread structure or other fixation element, as described herein. In some examples, a locking pin (eg, third locking pin 150) is inserted through fourth locking hole 36 prior to removing second drive pin 120B.

FIG. 15 shows bone plate 10 attached across the tarsometatarsal joint separating medial cuneiform bone 70 from first metatarsal bone 72. FIG. The bone plate is attached to the medial cuneiform 70 and the first metatarsal 72 using screws inserted through the first and second fixation holes 30, 34 of the bone plate. Depending on the configuration of the bone plate 10 in the procedure being performed, the clinician may remove the bone by placing screws into the underlying bone through the third fixation hole 32 and the fourth fixation hole 36, for example. You may proceed to complete installation of the plate.

However, in some applications, a clinician may desire to place multiple bone plates across a joint rather than only a single bone plate. Multiple bone plates may be placed at different locations around the joint to provide a biplanar plate fixation construct. In these applications, each bone plate and/or screw may be configured and installed according to the present disclosure, or one bone plate system may be different from the other bone plate system. In some such applications, the clinician may proceed to begin installing a second bone plate before completing installation of the first bone plate. For example, after the clinician has secured the first bone plate through the first fixation hole 30 and the second fixation hole 34, the clinician may select other fixation holes (e.g., third and/or fourth fixation holes). 32, 36), installation of the second bone plate may begin.

For example, FIGS. 16-22 illustrate example treatment steps that may be performed before, after, or in place of the treatment steps described with respect to FIGS. 10-15. As shown in FIG. 16, bone plate 10B may be placed over the tarsometatarsal joint separating metatarsal bone 72 from cuneiform bone 70. As shown in FIG. In the illustrated orientation, the bone plate 10B is placed inside the two bones (e.g., the innermost half, the innermost quarter), but it can also be placed in other locations around the bones. can.

Continuing to refer to FIG. 17, the first drive pin 120A may be inserted through the first fixation hole 30 located proximate to the area of the bone plate 10B that defines the apex of the bend. The drive pin 120A can be rotationally driven into the underlying bone (cuneiform 70) through the first fixation hole. As the drive pin drills axially into the bone, an enlarged region of the drive pin can contact a top surface of the bone plate (eg, a top surface of a drill guide that extends above the bone plate). Continued rotation of drive pin 120A causes the enlarged region of the drive pin to press against the bone plate, at least partially deforming the bend by compressing the bend, resulting in a relative flattening of the bone plate. Can be done.

As shown in FIG. 18, a second drive pin 120B may be inserted through a second fixation hole 34 located on the opposite side of the joint from the first drive pin 120A. The second fixation hole 34 may be located closest to the region of the bone plate 10 that defines the apex of the bend opposite the first fixation hole 30 . The second drive pin 120B can be rotationally driven into the underlying bone (metatarsal bone 72) through the second fixation hole. Again, as the drive pin drills axially into the bone, the enlarged region of the drive pin can contact the top surface of the bone plate (e.g., the top surface of a drill guide extending above the bone plate). . Continued rotation of the drive pin 120B can force the enlarged region of the drive pin against the bone plate, further deforming the bend in the bone plate that was initially deformed upon insertion of the first drive pin 120A. . Full insertion of the second drive pin 120B may complete deformation of the bone plate 10B to the desired degree of compression.

To hold the bone plate 10 for screw insertion, a third fixation pin 150 is inserted into a fixation hole in the bone plate adjacent to the fixation hole into which the screw is desirably inserted, as shown in FIG. obtain. In this example, the third fixation pin 150 is inserted into the underlying bone through the third fixation hole 32 of the bone plate 10. The third fixation pin can be configured similarly to the drive pin 120, or it can be a different configuration of a pin, such as an olive drive threaded plate tack or other pin. A third fixation pin 150 can be applied to hold the deformation and compression of the bone plate 10B (and the position of the bone plate). In other examples, the technique may proceed without installing the third fixation pin 150. The first drive pin 120A may be removed, but the second fixation pin 120B (or the screw through the opposite fixation hole) remains in place.

In either case, the first drive pin 120A can be removed from the first fixing hole 30 to open the fixing hole for installing a locking screw, as shown in FIG. After the first drive pin 120A is removed, a locking screw 50 (or other type of fixation element as described herein) is inserted through the first fixation hole 30 into the underlying bone. Can be screwed.

To secure the bone plate 10 to the cuneiform bone 70, the third fixation pin 150 (if used) is removed from the cuneiform bone with the locking screw 50 installed through the first fixation hole 30. can be done. Additionally, the second drive pin 120B can be removed from the metatarsal bone 72 and screws can be screwed into the second fixation holes 34 to secure the bone plate to the metatarsal bone. The screw inserted through the second fixation hole 34 can be a locking screw 50 or a different type of thread structure or other fixation element, as described herein. In some examples, a locking pin (eg, third locking pin 150) is inserted through fourth locking hole 36 prior to removing second drive pin 120B.

FIG. 21 shows bone plate 10B attached dorsally across the tarsometatarsal joint separating medial cuneiform 70 from first metatarsal 72. FIG. The bone plate is attached to the medial cuneiform 70 and the first metatarsal 72 using screws inserted through the first and second fixation holes 30, 34 of the bone plate.

The first bone plate 10 is secured with a single screw connecting the bone plate to the underlying bone portion (e.g., metatarsal 72), and then the first bone plate 10 is fixed before completing the installation of the first bone plate 10. Attaching two bone plates 10B may be useful for a variety of reasons. With only a single screw securing the first bone plate 10 to the bone portion, the bone portion may be further maneuverable during installation of the second bone plate 10B. For example, a clinician can pivot metatarsal bone 72 about a single screw connecting first bone plate 10 to the metatarsal bone. This allows for some degree of movement by the clinician to adjust the position of the first metatarsal in the transverse, coronal, and/or sagittal planes before or at the same time as installing the second bone plate 10B. flexibility or freedom. Additionally or alternatively, this arrangement provides mobility so that the bend 40 of the second bone plate 10B (if so configured) can deform to provide additional reinforcing correction of the bone portion. (e.g., laterally biasing the metatarsals to close the intermetatarsal angle).

Once the second bone plate 10B is attached to the medial cuneiform bone 70 and the first metatarsal bone 72 using screws inserted through the first and second fixation holes 30, 34 of the bone plate, the clinician can proceed to complete installation of the first bone plate 10 and/or the second bone plate 10B. For example, the clinician may enter the underlying bone through the third fixation hole 32 and fourth fixation hole 36 of the first bone plate 10 and/or the second bone plate 10B, as shown in FIG. You can install the screws to complete the installation.

It is to be understood that the foregoing description of exemplary procedural steps described in connection with FIGS. 10-22 are exemplary of the present invention, and that the procedures may be modified in accordance with the disclosure. For example, the clinician may install the medial bone plate before installing the dorsal bone plate, or may install only a single bone plate. As another example, the clinician may insert an initial drive pin and/or locking screw into the first metatarsal bone 72 through the first fixation hole instead of the medial cuneiform bone 70 as described in this example. can do. As a further example, the installation procedure may be modified to incorporate one or more additional fixation elements that may be used in addition to or in place of the bone plate fixation systems and techniques described. Exemplary additional fixation elements that may be used are between two bony portions, such as across the tarsometatarsal joint (e.g., through a first tarsometatarsal joint and into a second metatarsal joint). These include, but are not limited to, lag screws, pins, and/or staples inserted across the separation, and/or staples inserted across the tarsometatarsal joint.

When the bone plate fixation system according to the present disclosure is applied both dorsally and medially to the metatarsals and cuneiforms, the two bone plates may reinforce the realignment introduced during the bone realignment procedure. . For example, bone plates attached to the dorsal side of the metatarsals and cuneiforms are distributed asymmetrically to a greater degree on the plantar side of the joint than on the dorsal side of the joint, which can tend to plantarflex the metatarsals. force can be applied. Bone plates attached to the medial side of the metatarsals and cuneiforms can apply asymmetrically distributed forces that are greater on the lateral side of the joint than on the medial side, which forces the distal end of the metatarsal laterally can be biased to tend to close the intermetatarsal angle between the metatarsal bone to which the bone plate is attached and an adjacent metatarsal bone.

As mentioned above, the bone plate 10 may be placed on two bone sections that are fixed together with the plate. The bone plate may be placed over the bone portion in an undeformed state, for example before compressing the flexure 40. Once the bone plate is placed over one or both bone portions, the bone plate may be placed over one or both bone portions, for example by inserting one or more locking screws and/or drive pins or equivalent compression threaded elements through the fixation holes in the bone plate. , can be transformed. This may deform the bend of the bone plate towards a flatter profile.

In yet an additional example, the bone plate 10 having the bends 40 may be pre-tensioned prior to or concurrently with being placed over the joint between two adjacent bone portions to be fixed. Good (e.g. pre-compression). For example, using manual manipulation and/or a bending instrument, the bend portion 40 of the plate is compressed toward a more planar shape and held in compression while being placed across the joint between the bone portions being fixed. may be done. While held in compression, one or more drive pins and/or fixation elements (eg, screws) can be inserted through fixation holes in the bone plate and into the underlying bone portion.

In these examples, the bone plate 10 may have a configuration and be deformed according to any of the shape profiles and configurations described above, but the deformation may cause the bone plate to be distorted by causing the bone plate to be damaged by one or both of the underlying bone portions. occurs at least partially before being attached to. In these applications, at least one (and optionally all) fixation elements used to secure the pre-deformed bone plate to the underlying bone portion have a lower compression ratio (e.g. 1.5 It may be a non-locking screw or a locking screw configured with a compression ratio of less than 1.0, or one that is not effective to substantially deform the plate during installation, such as a compression ratio of 1.0. However, in some implementations, locking screws 50 with increased compression ratios (e.g., the most through one or both fixing holes).

23 and 24 illustrate one exemplary embodiment in which an instrument is used to pre-deform bone plate 10 prior to installation. FIG. 23 shows the bone plate 10 connected to a bending device 160 prior to compression, which in the illustrated example is shown as a plate bending arm. Plate bending arm 160 is inserted through the fixation hole in the bone plate on either side of drill guide 140 and/or bending section 40 . The handles can be squeezed together as shown in FIG. 24 to deform the bend of the bone plate 40 and pre-compress the bone plate. The handles can be squeezed together in the direction indicated by force vector arrow 162, for example, by one hand of the clinician grasping both handles and squeezing them together.

Once pre-compressed, a relatively flat plate can be placed over the two bone sections to be fixed together and held to one or both bone sections using drive pins or other fixation features. can. The plate bending arm 160 can then be removed, the screw hole prepared, and the screw screwed through the fixation hole in the plate and into the underlying bone.

If the bone plate 10 is pre-compressed prior to installation, the screws used to secure the plate to the underlying bone portion may include locking screws 50 as described above having a relatively high compression ratio. It does not have to be included. In some implementations, all screws utilized to secure the bone plate to the underlying bone portion may be non-locking screws or locking screws with a lower compression ratio.

In some implementations, components of the bone plate systems described herein (e.g., one or more bone plates, screws, and/or other fixation elements) may be provided as part of a kit. good. The kit may be a disposable, single-use surgical kit. The terms "disposable" and "single use" convey that the surgical kit, in addition to all components included in the surgical kit, is intended for use on only one surgical patient. It means that. After the surgical procedure for a surgical patient is completed, any components not implanted in the surgical patient can be discarded using conventional methods.

The kit can include a sterile container that can contain various surgical supplies. The container can be sterilized using any suitable sterilization means (eg, exposure to ethylene oxide, steam autoclaving, gamma irradiation). In one example, various surgical articles can be placed within the container, and the container and the various surgical articles contained therein can be sterilized in a single step. The sterile container may be partially or wholly enclosed within packaging that can serve to protect the container and seal and maintain the sterility of the container. The packaging and/or sterilization container can be made from a transparent material, such as a suitable polymer, to allow viewing of the surgical article contained within the container.

Disposable single use kits can include all or any combination of one or more of the surgical articles described. The items included in the kit may vary depending on the particular surgical procedure for which the kit is intended. Other embodiments of the kit can include two or more sterile packages with different components within each sterile package. For example, a first sterile package containing bone plates, fasteners, and pins may be provided with a second sterile package containing instruments such as plate manipulation and/or bone preparation instruments. Such kits may also be provided in modular form with components grouped together in separate sterile packages selected to provide a complete kit for the desired surgical procedure.

Various examples have been described. These and other examples are within the scope of the following claims.

Claims (42)

An orthopedic fixation system comprising:
a bone plate having a length defining a longitudinal axis extending from a proximal end of the body to a distal end of the body, the bone plate having a top surface and a bone-facing surface opposite the top surface; and the bone plate includes a first fixation hole extending through the body and a second fixation hole extending through the body, and the length of the bone plate is , one of the first fixation hole and the second fixation hole is disposed on the first bone portion, and the other of the first fixation hole and the second fixation hole is disposed on the second bone portion. the bone plate is sized to cross the separation when deployed, at least the first fixation hole includes a thread, and the bone plate defines the first fixation hole and the second fixation hole; a bone plate including a bend that offsets a portion of the bone plate between the first fixation hole and the second fixation hole with respect to a portion of the bone plate;
a locking screw having a head having a head thread and a shaft having a shaft thread, the locking screw having a compression ratio greater than 1.0; configured to be inserted into at least one of the first bone portion and the second bone portion through a first fixation hole, the head screw being defined by the first fixation hole. and the compression ratio is such that the head screw partially engages the thread defined by the first fixation hole and when the screw is further rotated, the compression ratio a locking screw effective to deform the plate;
Orthopedic fixation system with. 2. The system of claim 1, wherein the first bone portion and the second bone portion are two different bones, and the separation is a joint between the two different bones. 1 . The first bone portion is a metatarsal or a cuneiform, the second bone portion is the other of the metatarsal or the cuneiform, and the joint is a tarsometatarsal joint. Or the system described in 2. 4. The system of any one of claims 1-3, wherein at least one of the first bone portion and the second bone portion includes a metatarsal. The system of claim 1, wherein the first bone portion and the second bone portion are two portions of the same bone. 6. The system of claim 5, wherein the first bone portion and the second bone portion are two portions of a metatarsal bone, and the separation is a cut between the two portions. 7. The compression ratio according to any one of claims 1 to 6, wherein the compression ratio is greater than 1.5, such as greater than 1.7, greater than 1.9, greater than 2.1, or greater than 2.3. system. The second locking hole also includes a thread, the locking screw comprising a first locking screw and further comprising a second locking screw, the second locking screw having a head screw. a head having a thread, and a shaft having a shaft thread, the shaft thread having a pitch greater than a pitch of the head thread; and the compression ratio of the second locking screw. is greater than 1.5, the second locking screw is configured to be inserted into the other of the metatarsal and the cuneiform through the second fixation hole, and the second locking screw 8. A system according to any preceding claim, wherein the head thread of the screw is engaged with the threading defined by the second fixation hole. the bone plate has a length defining a longitudinal axis; the bone plate has a third fixation hole disposed between the first fixation hole and a first end of the bone plate; and a fourth fixation hole disposed between the second fixation hole and the second end of the bone plate. further comprising: a third screw configured to be inserted through the third fixing hole; and a fourth screw configured to be inserted through the fourth fixing hole, the third screw configured to be inserted through the fourth fixing hole. 10. The system of claim 9, wherein each of the and fourth screws is a non-locking screw or a locking screw exhibiting a compression ratio of less than 1.5. 9 or 9, wherein the first fixation hole, the second fixation hole, the third fixation hole, and the fourth fixation hole are coaxial with each other along the longitudinal axis of the bone plate. 10. The system according to 10. The bending portion that offsets the portion of the bone plate between the first fixation hole and the second fixation hole is configured to offset the portion of the bone plate between the first fixation hole and the second fixation hole. 12. A system according to any preceding claim, defined by a radius of curvature that offsets the portion of the plate in one dimension. 13. The system of any one of claims 1 to 12, wherein the bone plate and the locking screw are included in a sterile container as part of a kit. A method of applying a bone plate across a separation between a first bone portion and a second bone portion, the method comprising:
disposing a bone plate across a separation between a first bone portion and a second bone portion, the bone plate having a first fixation hole, a second fixation hole and the first bone plate; and a bent part between the fixation hole and the second fixation hole, and arranging the bone plate across the separation part means that there is a gap between the bone-facing surface of the bone plate and the separation part. arranging the bent portion over the separation portion having a
inserting a locking screw through the first fixing hole, the locking screw having a head having a head thread, and a shaft having a shaft thread; , having a compression ratio greater than 1.0, the first fixation hole including a thread for engaging the head thread;
The locking screw is inserted into the first locking screw below the first locking hole until the head thread of the locking screw partially engages the threading defined by the first locking hole. Screwing into the bone part,
further threading the locking screw into the first bone portion, thereby deforming the bend in the bone plate toward the separation portion;
including methods. 15. The method of claim 14, wherein the first bone portion and the second bone portion are two different bones, and the separation is a joint between the two different bones. 15. The first bone portion is a metatarsal or cuneiform, the second bone portion is the other of the metatarsal or cuneiform, and the joint is a tarsometatarsal joint. 15. The method described in 15. 17. The method of any one of claims 14-16, wherein at least one of the first bone portion and the second bone portion comprises a metatarsal. 15. The method of claim 14, wherein the first bone portion and the second bone portion are two portions of the same bone. 19. The method of claim 18, wherein the first bone portion and the second bone portion are two portions of a metatarsal bone, and the separation is a cut between the two portions. 20. A method according to any one of claims 14 to 19, wherein the compression ratio of the locking screw is at least 1.5. 21. A method according to any one of claims 14 to 20, wherein the compression ratio is greater than 1.7, such as greater than 1.9, greater than 2.1, or greater than 2.3. 22. A method according to any one of claims 14 to 21, wherein the bone plate defines a thickness in the range 1.0 mm to 2 mm. Before screwing the locking screw into the first bone part, the first bone part is secured by inserting at least a locking pin through the end face of the first bone part and into the end face of the second bone part. 23. A method according to any one of claims 14 to 22, further comprising temporary fixation to the second bone portion. 24. Any one of claims 14-23, further comprising inserting a screw through the second fixation hole and threading the screw into the second bone portion below the second fixation hole. The method described in. the second screw also includes a head having head threads and a shaft having shaft threads, the second screw having a compression ratio greater than 1.0;
the second fixing hole includes a thread for engaging the head thread of the second screw;
Threading the second screw into the second bone portion includes: screwing the second screw into the second bone portion until the head threads of the second screw partially engage the threads defined by the second fixation hole; screwing a second screw; and further screwing the second screw into the second bone portion;
25. The method of claim 24, comprising: the gap between the bone-facing surface of the bone plate and the separation portion is at least 1.75 mm;
Further threading the locking screw into the first bone portion, thereby deforming the bend in the bone plate toward the separation, reduces the gap to a distance of less than 1.5 mm. to do,
26. A method according to any one of claims 14 to 25, comprising: Deforming the bend in the bone plate toward the separation includes establishing an asymmetric distributed load across an end of the first bone portion and an end of the second bone portion; 27. Any one of claims 14 to 26, wherein the asymmetric distributed load has a greater magnitude on the side of the first bone part and the second bone part opposite to the side on which the bone plate is placed. The method described in. The bone plate has a length defining a longitudinal axis, the first fixation hole is spaced apart from the second fixation hole, and the first fixation hole is on one side of the separation. 28. A method according to any one of claims 14 to 27, wherein the second fixation hole is on the other side of the separation part. The bone plate has a third fixation hole disposed between the first fixation hole and the first end of the bone plate, and a second fixation hole and a second end of the bone plate. 29. The method of claim 28, further comprising: a fourth fixation hole disposed between the first and second fixing holes. 30. The first fixation hole, the second fixation hole, the third fixation hole, and the fourth fixation hole are coaxial with each other along the longitudinal axis of the bone plate. Method described. The bone plate further includes at least one branch extending outwardly from the longitudinal axis of the bone plate to define at least one of a Y-shape, an L-shape, a T-shape, and a U-shape. 31. A method according to any one of claims 28 to 30, comprising: before inserting the locking screw through the first fixing hole;
screwing a drive pin through the first fixation hole and into the first bone portion below the first fixation hole, the drive pin extending from a proximal end to a distal end; Further, the drive pin includes a threading adjacent the distal end and an enlarged region having a cross-sectional size greater than a cross-sectional size of the first fixation hole spaced proximally from the distal end. including,
Screwing the drive pin through the first fixation hole at least until the enlarged region presses against the upper side of the bone plate, thereby deforming the bending part of the bone plate towards the separation part. 32. A method according to any one of claims 14 to 31, comprising screwing the drive pin through a first fixation hole and into the first bone part below the first fixation hole. The bone plate has a length defining a longitudinal axis, the first fixation hole is spaced apart from the second fixation hole, and the first fixation hole is on one side of the separation. , the second fixation hole is on the other side of the separation section, and the bone plate has a third fixation hole disposed between the first fixation hole and the first end of the bone plate. and a fourth fixation hole disposed between the second fixation hole and the second end of the bone plate. the method of. inserting a first drive pin into the first bone portion through the first fixation hole;
inserting a second drive pin into the second bone portion through the second fixation hole;
inserting a third drive pin into the first bone portion through the third fixation hole;
before inserting the locking screw into the first fixing hole, removing the first drive pin from the first fixing hole, and inserting the locking screw through the first fixing hole. Inserting means that the second driving pin is inserted through the second fixing hole, the third driving pin is inserted through the third fixing hole, and the second driving pin is inserted through the first fixing hole. inserting the locking screw;
34. The method of claim 33, comprising: The locking screw includes a first locking screw and further includes a second locking screw, the second locking screw having a head having a head thread and a shaft having a shaft thread. and the second locking screw has a compression ratio greater than 1.0, and the second locking hole engages the head thread of the second locking screw. Includes threading for
inserting the second locking screw through the second locking hole until the head thread of the second locking screw engages the threading defined by the second locking hole; screwing the second locking screw into the second bone portion below the second fixation hole;
After inserting the first locking screw and the second locking screw, inserting a third screw into the first bone portion through the third fixation hole and through the fourth fixation hole. 35. The method of claim 33 or 34, further comprising inserting a fourth screw into the second bone portion. the compression ratio of the first locking screw and the second locking screw is each at least 1.5;
each of the third screw and the fourth screw is a non-locking screw or a locking screw exhibiting a compression ratio of less than 1.5;
36. The method of claim 35. The first bone portion is a metatarsal or cuneiform, the second bone portion is the other of the metatarsal or cuneiform, the joint is a tarsometatarsal joint, and the metatarsal Before placing the bone plate over the ankle joint,
preparing an end of the metatarsal;
preparing an end of the cuneiform bone;
37. The method of claims 14-36, further comprising: moving the metatarsal in at least the transverse plane to close an intermetatarsal angle between the metatarsal and an adjacent metatarsal. The method described in any one of the above. 38. Positioning the bone plate over the tarsometatarsal joint includes positioning the bone plate on at least one of the dorsal and medial side of the metatarsal and the cuneiform. Method described. 39. The method of claim 37 or 38, wherein the metatarsal is a first metatarsal and the cuneiform is a medial cuneiform. Placing the bone plate over the tarsometatarsal joint includes placing a first bone plate on the dorsal side of the tarsometatarsal joint and a second bone plate on the medial side of the tarsometatarsal joint. disposing a plate, the first bone plate and the second bone plate each having a first fixation hole on one side of the tarsometatarsal joint and a second bone plate disposed in the first bone plate on one side of the tarsometatarsal joint; the second fixation hole on the other side of the bone plate; a third fixation hole between the first fixation hole and the first end of the bone plate; and the second fixation hole and the bone plate. 40. A method according to any one of claims 37 to 39, comprising a fourth fixation hole disposed between the second end of the fourth fixing hole. The first bone plate is arranged such that the locking screw is inserted into one of the first fixation hole and the second fixation hole of the first bone plate, and the locking screw is inserted into one of the first fixation hole and the second fixation hole of the first bone plate. installed by inserting a secondary screw into the other of the first fixing hole and the second fixing hole,
Prior to inserting screws through the third fixation hole and the fourth fixation hole of the first bone plate, the second bone plate is inserted into the first fixation hole of the second bone plate and inserting the locking screw through one of the second fixation holes and inserting a secondary screw through the other of the first fixation hole and the second fixation hole of the second bone plate; established by
41. The method of claim 40. A method,
a bone plate having a first fixation hole, a second fixation hole, and a bend between the first fixation hole and the second fixation hole; tensioning by bending toward the profile, thereby providing a tensioned bone plate;
placing the tensioned bone plate across the tarsometatarsal joint separating the metatarsal from the cuneiform;
inserting a screw through the first fixing hole, the screw having a head with a head thread and a shaft with a shaft thread; including a threading for engaging the head thread;
The locking screw is inserted into the metatarsal or the cuneiform below the first fixation hole until the head thread of the locking screw engages the threading defined by the first fixation hole. screwing into the bone,
including methods.

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